Recro Pharma (REPH +4.9%) finalizes its public offering of 6.67M common shares at $6. Net proceeds of ~$36.9M will fund the NDA and preparations for commercial activities for IV meloxicam and the planned Phase 3b program as well as general corporate purposes.
In a regulatory filing, Recro Pharma (REPH -5%) reports that it has amended its Purchase and Sale Agreement with Alkermes (ALKS +0.2%) related to a potential $10M milestone payment that will be triggered upon the filing of a New Drug Application (NDA) for intravenous (IV) meloxicam. If Recro exercises its option to defer payment, the milestone due Alkermes will be increased to $15M. This would increase the aggregate milestone due Alkermes to $45M upon NDA approval.
Recro acquired global rights to the product candidate and a contract manufacturing facility from Alkermes in March of last year.
A Phase 3 clinical trial assessing Recro Pharma's (NASDAQ:REPH) IV meloxicam for the treatment of serious acute pain met its primary endpoint of a statistically valid difference in pain relief compared to placebo in patients following abdominoplasty surgery.
Study participants (n=219) were randomized 1:1 to receive either IV meloxicam or placebo once every 24 hours following surgery. The IV meloxicam cohort showed a statistically significant reduction in pain intensity as measured by a scale called SPID24 versus placebo (p=0.0145). The trial also achieved 10 secondary endpoints.
IV meloxicam was well-tolerated with no difference in the incidence of serious adverse events related to bleeding compared to placebo (one each). The most common adverse events in the IV meloxicam group were nausea, headache, vomiting and dizziness. All occurred less frequently than the placebo cohort. The majority were mild in nature.
The company intends to submit the data for presentation at a future scientific conference or for publication. It expects to file a New Drug Application (NDA) in the U.S. next summer.
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Insys Therapeutics (NASDAQ:INSY) is ahead 9% premarket on increased volume in response to its announcement of successful results in its Phase 3 study assessing Buprenorphine Sublingual Spray for the treatment of moderate-to-severe postoperative pain in patients undergoing bunionectomy, a procedure that requires an incision on the top or side of the big toe joint.
The primary endpoint was the summed pain intensity difference over 48 hours. The three dosages of Buprenorphine evaluated (0.5 mg 3x/day, 0.25 mg 3x/day, 0.125 mg 3x/day) were all statistically significantly better than placebo with the highest dose showing the largest reduction (expected for a pain medication).
The company plans to discuss the results with the FDA by year end as well as the steps required to file a New Drug Application (NDA).
Recro Pharma (NASDAQ:REPH) prices its public offering of 1,986,666 shares of common stock at $7.50. Closing date is August 19. Net proceeds will fund the continued clinical development of injectable meloxicam and general corporate purposes.